The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
NCT ID: NCT05793996
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2023-04-28
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental: 1
Drug: Ferinject ® (Ferric carboxymaltose)
Ferinject
The calculation of the dose of iron carboxymaltosate (Ferinject ® preparation) for the purpose of correction of iron will be carried out on the basis of the following step-by-step approach: determination of individual iron needs, calculation and administration of iron dose, assessment of the saturation of the patient's body with iron 6 weeks after infusion.
Comparison Group: 2
Diet therapy, without drug therapy
Diet therapy
Patients will receive diet therapy to correct latent iron deficiency
Control Group: 3
Without therapy
No interventions assigned to this group
Interventions
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Ferinject
The calculation of the dose of iron carboxymaltosate (Ferinject ® preparation) for the purpose of correction of iron will be carried out on the basis of the following step-by-step approach: determination of individual iron needs, calculation and administration of iron dose, assessment of the saturation of the patient's body with iron 6 weeks after infusion.
Diet therapy
Patients will receive diet therapy to correct latent iron deficiency
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF);
* Left ventricular ejection fraction (LVEF) ≥50%; objective signs of structural and/or functional disorders of the heart consistent with the presence of LV diastolic dysfunction/increased LV filling pressure, including elevated levels of natriuretic peptide;
* Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%;
* Screening haemoglobin (Hb) at the time of switching on ( 90-150 g/l).
Exclusion Criteria
* Аnemia not related to iron deficiency;
* Аnemia with a hemoglobin level of less than 90 g/l;
* Less than 1 year after acute myocardial infarction;
* Less than 1 year after acute cerebral circulation disorder;
* Less than 1 year after surgical interventions, including non-cardiac operations and myocardial revascularization (coronary bypass surgery, coronary artery stenting), operations for valvular pathology;
* Chronic alcoholism (including alcoholic heart disease), mental disorders;
* Severe hepatic (increased transaminase levels above the upper three limits of normal) and renal insufficiency (glomerular filtration rate less than 15 ml/min/1.73 m2);
* Known active infection, clinically significant bleeding, active malignancy;
* Severe autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.);
* Severe bronchial asthma, COPD in the acute stage;
* Allergic reactions to medications in the anamnesis, eczema, atopic allergic reaction;
* Blood transfusions and taking erythropoiesis-stimulating drugs during the previous three months.
18 Years
ALL
No
Sponsors
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Tomsk National Research Medical Center of the Russian Academy of Sciences
OTHER
Responsible Party
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Principal Investigators
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Alla A. Garganeeva, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Locations
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Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ID-HFpEF
Identifier Type: -
Identifier Source: org_study_id